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HIV/AIDSNCT04038060

The PrEP (Pre-exposure Prophylaxis) SMART Study

A study testing WhatsApp Group, 2-way SMS and Drug level feedback in people with HIV/AIDS, run by University of Washington at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design. Read more about this study

Who is it for?
Ages 18 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
HIV/AIDS
What is being tested?
WhatsApp Group, 2-way SMS and Drug level feedback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteSouth Africa
Study dates
16 May 2019to 25 Jan 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Female at birth
  • Age 18-25 years
  • Per participant report, sexually active, defined as having vaginal or anal intercourse at least once in the month prior to screening
  • Literate in one or more of the study languages
  • Willing and able to provide informed consent
  • Able and willing to provide adequate locator information
  • Regular access to a mobile phone with SMS and WhatsApp capacity
  • Agrees not to participate in other research studies involving drugs or medical devices for the duration of study participation

Who cannot join

  • Planning to relocate in the next 12 months
  • Has a job or other obligations that would require long absences from the area (> 4 weeks at a time) for 12 months
  • A reactive or positive HIV test at Enrollment
  • Any reported PrEP use within the last 6 months
  • Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents
  • Prior participation in the active arm, or current participation in any arm, of an HIV vaccine trial
  • Positive pregnancy test

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Wits Reproductive Health and HIV Institute

    Johannesburg

Other trials in South Africa

About this study

Official title: Evaluation of Stepped PrEP (Pre-exposure Prophylaxis) Adherence Support for Young South African Women Using a SMART Design

The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design.

Read the detailed description

Women enrolled in the study will be randomized to standard of care adherence support (brief counseling) and either WhatsApp groups or weekly two-way SMS messages. Two months after PrEP initiation, tenofovir drug levels will be measured to determine if participants have achieved high adherence based on their initial randomization. Women with high adherence (i.e., TFV-DP >/=500 fmol/punch from dried blood spots [DBS]) will continue with the adherence support to which they were initially randomized. Participants with low adherence (i.e., TFV-DP <500 fmol/punch from DBS) will continue initial randomization (WhatsApp or two-way SMS) plus be randomized to more one of two more intensive adherence support interventions - continued monthly visits with adherence and problem-focused counseling at months 3-8 or quarterly visits between months 3-9 with feedback about adherence based on drug levels at months 3 and 6.

Conditions
HIV/AIDS
Being tested
WhatsApp Group, 2-way SMS, Drug level feedback, Monthly counseling sessions
Keywords
pre-exposure prophylaxis, young women, HIV infections/prevention, SMART design
Medical subject headings
Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WhatsApp GroupBehavioural

    Participants will receive peer adherence support through WhatsApp groups

  • 2-way SMSBehavioural

    Participants will receive healthcare worker adherence support through 2-way SMS

  • Drug level feedbackBehavioural

    Participants will receive adherence counseling based on tenofovir drug levels

  • Monthly counseling sessionsBehavioural

    Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence

Study groups in NCT04038060
Study groupRoleWhat they receive
WhatsApp GroupExperimentalParticipants will be assigned to participate in a WhatsApp Group
Receives: Behavioral: WhatsApp Group
2-way SMSExperimentalParticipants will be assigned to receive weekly 2-way SMS initiated by the study team
Receives: Behavioral: 2-way SMS
2-way SMS and monthly counseling sessionsExperimentalParticipants will be assigned to receive weekly 2-way SMS initiated by the study team and monthly counseling sessions
Receives: Behavioral: 2-way SMS; Behavioral: Monthly counseling sessions
2-way SMS and drug level feedbackExperimentalParticipants will be assigned to receive weekly 2-way SMS initiated by the study team and drug level feedback
Receives: Behavioral: 2-way SMS; Behavioral: Drug level feedback
WhatsApp Group and monthly counseling sessionsExperimentalParticipants will be assigned to participate in a WhatsApp Group and monthly counseling sessions
Receives: Behavioral: WhatsApp Group; Behavioral: Monthly counseling sessions
WhatsApp Group and drug level feedbackExperimentalParticipants will be assigned to participate in a WhatsApp Group and drug level feedback
Receives: Behavioral: WhatsApp Group; Behavioral: Drug level feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PrEP Adherence

    Evaluation of the proportion of young women who adhere well to PrEP in each of the original intervention arms.

    Measured: 9 months

Secondary outcomes (2)

  1. Probability of High PrEP Adherence at Nine Months

    Estimated probability of high PrEP adherence (tenofovir diphosphate levels greater than or equal to 700 fmol/punch at 9 months) by embedded dynamic treatment strategy.

    This analysis employed a weighted and replicated approach to account for non-response, re-randomization, and overlap in intervention assignments (e.g., the same participants in the SMS intervention were represented twice in two of the four interventions). Weighting accounted for over-representation of people who responded, whereas replicating responder observations across the two embedded dynamic treatment strategies with the same first-line treatment accounted for one participant being able to be in two treatment strategies.

    Measured: 9 months

  2. PrEP Discontinuation

    Assessment of the timing of PrEP discontinuation in young women who discontinue PrEP, reported by original intervention arm.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2019
  2. Study start16 May 2019
  3. Primary completion27 Oct 2021
  4. Study completion25 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Model description
Sequential multiple assignment randomized trial (SMART)
Masking
Single blind
Who is masked
Investigator
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04038060
Sponsor's protocol ID
STUDY00006439
Other IDs
R01MH114544
Status last verified
Apr 2025
First submitted
19 Jun 2019
Last updated
4 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data from the PrEP SMART Study will be available at the end of the project by contacting the Principal Investigators.

Publications

  • Velloza J, Poovan N, Meisner A, Ndlovu N, Ndimande-Khoza N, Grabow C, Zwane P, Mbele S, Molefe M, Donnell D, Baeten JM, Hosek S, Celum C, Delany-Moretlwe S. Adaptive HIV pre-exposure prophylaxis adherence interventions for young women in Johannesburg, South Africa: a sequential multiple-assignment randomised trial. Lancet HIV. 2025 Feb;12(2):e105-e117. doi: 10.1016/S2352-3018(24)00268-6. Epub 2024 Dec 13.

    PubMed 39681126

  • Velloza J, Poovan N, Ndlovu N, Khoza N, Morton JF, Omony J, Mkwanazi E, Grabow C, Donnell D, Munthali R, Baeten JM, Hosek S, Celum C, Delany-Moretlwe S. Adaptive HIV pre-exposure prophylaxis adherence interventions for young South African women: Study protocol for a sequential multiple assignment randomized trial. PLoS One. 2022 Apr 13;17(4):e0266665. doi: 10.1371/journal.pone.0266665. eCollection 2022.

    PubMed 35417485

Questions about this trial

What is this clinical trial studying?

A study testing WhatsApp Group, 2-way SMS and Drug level feedback in people with HIV/AIDS, run by University of Washington at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PrEP Adherence (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04038060, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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